Flexible forehead support

ABSTRACT

A respiratory mask includes a mask frame and a forehead support provided to the mask frame. The forehead support includes a base extending from the frame. The base includes a flexible portion along at least a portion of its length including a material and/or physical characteristic that allows the base to flex from an original, unloaded position.

CROSS-REFERENCE TO APPLICATION

This application claims the benefit of Australian ProvisionalApplication No. AU 2007903360, filed Jun. 22, 2007, which isincorporated herein by reference in its entirety.

FIELD OF THE INVENTION

The present invention relates to a respiratory mask, and moreparticularly, to a forehead support for a respiratory mask.

BACKGROUND OF THE INVENTION

FIG. 1 illustrates a respiratory mask produced by ResMed including aforehead support (e.g., see U.S. Pat. No. 6,532,961). The ResMedforehead support has two primary functions. The first primary functionis to stabilize the cushion on the patient's face to facilitate a seal.The forehead support mainly acts to prevent axial rotation about thehorizontal and median axes as shown in FIG. 1.

The second primary function is to correctly locate the cushion againstthe patient's facial profile, again facilitating the generation of aseal. In prior forehead supports produced by ResMed, the two variablescontrolled by the forehead support are the displacement of the cushion(depicted by X in FIG. 2 a) in the horizontal plane and also the angle(depicted by θ in FIG. 2 a) of the cushion's sealing surface to thefrontal plane. FIGS. 2 a to 2 c illustrate alternative positions of theforehead support to vary the displacement and angle of the cushion. Byallowing variations in the displacement and angle of the cushion, acompromise between generation of a seal and prevention of excessiveforce on sensitive areas, such as the nasal bridge, can be achieved,thus maximizing patient comfort.

Adjustment of the displacement and angle can also be used to maximizethe contact area between the forehead support and the patient'sforehead. By maximizing the contact area, the overall force on thepatient's forehead may be reduced, which improves patient comfort.

SUMMARY OF THE INVENTION

A first aspect of the present invention relates to the provision of aflexible and/or resilient forehead support for a respiratory mask.

One advantage of embodiments of the invention is that the foreheadsupport is auto-fitting. This is beneficial because it overcomes theproblems arising from the fact that some patients do not realize thatthe forehead support is adjustable, do not adjust it correctly, and/orhave difficulty adjusting it while wearing the mask because of dexterityand/or the lack of line of sight (i.e., you cannot easily see somethingthat is between your eyes).

Another advantage of embodiments of the invention is that, as comparedto a typical adjustable forehead support, at least one if not morecomponents can be eliminated from the design. This is beneficial inthat: (1) design complexity is reduced leading to cost savings in thedesign process, (2) at least one part is removed providing a reductionin the cost of goods, and (3) there are less assembly steps resulting ina reduction in assembly time and associated cost savings. It is alsosimpler for patients as there is no intricate reassembly of the foreheadsupport required after cleaning.

A second aspect of the present invention relates to the provision of anadjustable forehead support using one or more resilient elements thatmay or may not be integrated with one or more rigid or semi-rigidelements. If more than one resilient element is provided, each elementcould have a different spring constant. The resilient elements may bejoined to the rigid or semi-rigid elements by over-molding, adhesive, orother suitable manufacturing technique.

In this specification, the word “resilient” is used to describe anymaterial that under normal usage conditions in this context exhibits arange of elastic deformation in response to a force applied to thematerial that is sufficient to allow the forehead support to flex acrossa useful angular range in any plane or to extend or compress axially.

A third aspect of the present invention relates to the provision of anadjustable forehead support comprising one or more regions of reducedcross-sectional area or reduced outer cross-sectional footprint that areresilient. These regions may take the form of substantially superposedrecesses or an array of recesses that are disposed around at least aportion of an outer surface of the forehead support. These recesses maybe disposed transversely to the main axis of the mask. In oneembodiment, these recesses are disposed perpendicularly to the main axisof the mask.

In one variation of the third aspect, one or more layers of moreresilient or flexible material may be provided adjacent each region ofreduced cross-sectional area or reduced outer cross-sectional footprint.Each layer may provide a spring or dampening function and may be joinedto each region by over-molding, adhesive or another suitablemanufacturing technique.

One advantage of some embodiments of this invention is a controlledamount of torsional flexation or resilience can be provided. This can bebeneficial to patients who have an asymmetric facial profile or topatients who do not have their mask located correctly on their face.

Another aspect of the present invention is the provision of arespiratory mask having a forehead support of any one of the embodimentsof the present invention.

Another aspect of the present invention is the provision of arespiratory mask system having a forehead support of any one of theembodiments of the present invention.

Another aspect of the present invention is a method of fitting arespiratory mask to a patient comprising: (1) locating the cushion onthe patient's face, (2) placing the headgear straps around the patient'shead; and (3) allowing the forehead support to automatically attain acustomized orientation.

Another aspect of the present invention relates to a respiratory maskincluding a mask frame and a forehead support provided to the maskframe. The forehead support includes a base extending from the frame.The base includes a flexible portion along at least a portion of itslength including a material and/or physical characteristic that allowsthe base to flex from an original, unloaded position.

Another aspect of the present invention relates to a respiratory maskincluding a mask frame and a forehead support provided to the maskframe. The forehead support includes a base extending from the frame.The base includes a flexible portion along at least a portion of itslength which allows the base to flex from an original, unloadedposition. The flexible portion is constructed of a different materialthan the remainder of the base.

Another aspect of the present invention relates to a respiratory maskincluding a mask frame and a forehead support provided to the maskframe. The forehead support includes a base extending from the frame.The base includes a bendable portion along at least a portion of itslength which allows the base to bend from an original position to anadjusted position such that the bendable portion retains the adjustedposition for forces less than a certain limit. The bendable portionincludes a deformable or malleable material.

Another aspect of the present invention relates to a respiratory maskincluding a mask frame adapted to support an elbow and a foreheadsupport integrally formed in one piece with the mask frame. The foreheadsupport includes a general “T”-shape with a base extending from theframe and an upper cross-portion provided to the base. The base includesa flexible portion along at least a portion of its length that isconstructed of a resilient material that allows the base to flex from anoriginal, unloaded position and substantially return to its originalposition when not loaded.

Another aspect of the present invention relates to a respiratory maskincluding a mask frame and a forehead support provided to the maskframe. The forehead support includes a base extending from the frame.The base includes a flexible portion along at least a portion of itslength that allows the forehead support to flex across a useful angularrange in any plane and/or to extend or compress axially.

Other aspects, features, and advantages of this invention will becomeapparent from the following detailed description when taken inconjunction with the accompanying drawings, which are a part of thisdisclosure and which illustrate, by way of example, principles of thisinvention.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings facilitate an understanding of the variousembodiments of this invention. In such drawings:

FIG. 1 is a front perspective view of a prior art mask including aforehead support;

FIGS. 2 a to 2 c are side views of the prior art mask of FIG. 1 showingvarious positions of the forehead support;

FIGS. 3-1 to 3-7 are various views of a respiratory mask including aforehead support according to an embodiment of the present invention;

FIGS. 4-1 to 4-8 are various views of a frame of the mask shown in FIGS.3-1 to 3-7;

FIG. 5 is a side view of the mask shown in FIGS. 3-1 to 3-7 showingflexing in opposing directions according to an embodiment of the presentinvention;

FIG. 6 is a side view of the mask shown in FIGS. 3-1 to 3-7 showing arange of movement of the forehead support according to an embodiment ofthe present invention;

FIGS. 7-1 and 7-2 are side views of the mask shown in FIGS. 3-1 to 3-7showing an orientation of the forehead support according to anembodiment of the present invention;

FIGS. 8-1 and 8-2 are side views of the mask shown in FIGS. 3-1 to 3-7showing an orientation of the forehead support according to anotherembodiment of the present invention;

FIG. 9 is a side view of the mask shown in FIGS. 3-1 to 3-7 showing anorientation of the forehead support according to another embodiment ofthe present invention;

FIG. 10 is a side view of the mask shown in FIGS. 3-1 to 3-7 showing aspring constant variable of the forehead support according to anembodiment of the present invention;

FIG. 11 is a graph showing a range of spring constants of the foreheadsupport according to an embodiment of the present invention;

FIG. 12 is a front view of the mask shown in FIGS. 3-1 to 3-7 showinglimited axial rotation of the forehead support according to anembodiment of the present invention;

FIG. 13 a and 13 b are front and side views of the mask shown in FIGS.3-1 to 3-7 illustrating various cross-sectional thicknesses of theforehead support according to an embodiment of the present invention;

FIG. 14 is a front view of a mask including a forehead support withhorizontal ridges according to an embodiment of the present invention;

FIGS. 15-1 to 15-8 are various views of an elbow of the mask shown inFIGS. 3-1 to 3-7;

FIG. 15-9 is a cross-sectional view illustrating attachment of the elbowto the frame according to an embodiment of the present invention;

FIGS. 16-1 to 16-4 are various views of a swivel joint of the mask shownin FIGS. 3-1 to 3-7;

FIGS. 17-1 to 17-2 are front and side views of a mask including aforehead support with different materials according to an embodiment ofthe present invention;

FIGS. 17-3 to 17-4 are side views of the mask shown in FIGS. 17-1 to17-2 with the forehead support in first and second deformed positions;

FIG. 18 is a side view of a mask including a forehead support with amalleable support member according to an embodiment of the presentinvention;

FIG. 19 is a side view of a mask including a forehead support with firstand second flexible portions according to an embodiment of the presentinvention; and

FIGS. 20-1 and 20-2 are side views of a mask including a foreheadsupport according to another embodiment of the present invention.

DETAILED DESCRIPTION OF ILLUSTRATED EMBODIMENTS

The following description is provided in relation to several embodimentswhich may share common characteristics and features. It is to beunderstood that one or more features of any one embodiment may becombinable with one or more features of the other embodiments. Inaddition, any single feature or combination of features in any of theembodiments may constitute additional embodiments.

In this specification, the word “comprising” is to be understood in its“open” sense, that is, in the sense of “including”, and thus not limitedto its “closed” sense, that is the sense of “consisting only of”. Acorresponding meaning is to be attributed to the corresponding words“comprise”, “comprised” and “comprises” where they appear.

The term “air” will be taken to include breathable gases, for exampleair with supplemental oxygen.

1. First Embodiment of Forehead Support

FIGS. 3-1 to 3-7 illustrates a respiratory mask 10 including a foreheadsupport 20 according to an embodiment of the present invention. In thisembodiment, the mask 10 includes a nasal interface. As illustrated, themask 10 includes a frame 30, a cushion 40 provided to the frame 30 andadapted to form a seal with the patient's face, an elbow 50 provided tothe frame 30 and adapted to be connected to an air delivery tube thatdelivers breathable gas to the patient, and a forehead support 20 toprovide a support and stability mechanism between the mask 10 and thepatient's forehead. A headgear assembly (not shown) may be removablyattached to the frame 30 and the forehead support 20 to maintain themask 10 in a desired adjusted position on the patient's face. The mask10 is intended for use in positive pressure therapy for users withobstructive sleep apnea (OSA) or another respiratory disorder.

While the forehead support 20 is described as being implemented into anasal mask, it may be adapted for use with other suitable interfacetypes. That is, the interface type is merely exemplary, and eachembodiment may be adapted to include other interface types, e.g., fullface interface, nasal pillows, prongs, etc.

1.1 Frame/Forehead Support

In the illustrated embodiment, the frame 30 and forehead support 20 areintegrally formed as a one-piece structure. For example, the frame 30and forehead support 20 may be a single part manufactured from a singlematerial.

As shown in FIGS. 4-1 to 4-8, the frame 30 includes inner and outerwalls that define an annular channel 32 structured to retain the cushion40. The cushion 40 may include various configurations, e.g., dual wall,gusseted, and/or cushions similar to ResMed's Mirage Vista™ mask orResMed's Mirage Micro™ mask, etc.

The frame 30 also includes a tube portion 34 structured to retain theelbow 50, as described in greater detail below.

In addition, headgear connectors 36 are provided to respective sides ofthe frame 30. Each headgear connector 36 is in the form of an outriggerincluding an elongated arm 36(1) and a tab portion 36(2) that provides aslot 36(3) adapted to receive a respective headgear strap in use (e.g.,see FIGS. 3-1 and 4-1). In an embodiment, each slot 36(3) may beopen-ended (e.g., see FIG. 14).

The forehead support 20 extends from a top of the frame 30. The foreheadsupport 20 has a general “T”-shape, with a base 22 and an upper crossportion 24. The upper cross portion 24 provides a pair of arms 24(1),and each arm 24(1) includes a slot 24(2) adapted to receive a respectiveheadgear strap (e.g., see FIGS. 3-1 and 4-3). In an embodiment, eachslot 24(2) may be open-ended.

In addition, the upper cross-portion 24 may be structured to retain oneor more forehead pads (e.g., elastomeric, gel, or foam pad). In analternative embodiment, a headgear strap from the headgear may be usedas forehead padding as described in Australian Provisional ApplicationNo. AU 2007903361, filed Jun. 22, 2007, entitled “Forehead Support for aFacial Mask”, which is incorporated herein by reference in its entirety.

As described in greater detail below, the base 22 of the foreheadsupport 20 is contoured along its length and includes a flexible and/orresilient portion 25 along at least a portion of the base's length whichallows the forehead support to flex across a useful angular range in anyplane and/or to extend or compress axially in use. In an embodiment, thebase 22 provides a low profile (e.g., see FIGS. 3-7 and 4-8) that iscontoured to substantially match the curvature of the patient's facewith minor adjustment provided by the flexible portion 25 of the base22. In an embodiment, the entire length of the base and/or upper crossportion may be bendable to intimately follow the facial contours of thepatient's face.

Such arrangement provides the forehead support 20 with a range ofadjustment and allows the forehead support to be auto-fitting whereinthe forehead support may automatically attain a customized orientation.That is, the forehead support 20 does not include an adjustmentmechanism per se that needs to be manually adjusted by the patient inorder to fit the mask to the patient's face.

In addition, the flexible forehead support 20 may provide a force toseal the cushion 40 over the patient's nasal bridge. In an embodiment,the magnitude of forces to flex the forehead support may be similar tothe magnitude of forces to deform the mask seal or cushion (e.g., forcesare balanced), which helps to ensure a seal when the forehead support issufficiently tightened into position. In an embodiment, the foreheadsupport may be structured to redistribute forces on the cushion.

The base 22 of the forehead support 20 extends along the dead space inthe patient's field of view (between the eyes) so it is notsubstantially in the patient's field of view in use, i.e., unobtrusiveand eliminates interference with bedding material. Optimally, theforehead support 20 is not visible at all by the patient in use.

It should be appreciated that the illustrated forehead support 20 isexemplary and other suitable arrangements are possible. For example, theupper cross portion 24 may be shorter or longer in length, may includetapered ends to reduce material, and/or may be wider to increase surfacearea of contact. Many different geometries of the upper cross portion 24may be adopted in order to provide a relatively large surface area andhence low contact pressure and to improve lateral stability of the maskin use. In an embodiment, the forehead support 20 may merely include thebase 22 with an end that provides spaced-apart openings for loopingrespective headgear straps (e.g., I-beam construction).

1.2 Flexibility

In the illustrated embodiment, the flexible or flexing portion 25 of thebase 22 allows the forehead support 20 to flex from an original,unloaded position in opposing directions as shown in FIG. 5. In anembodiment, the forehead support 20 may flex up to 50 mm in eitherdirection from its original unloaded position. The force displacementcurve may have a linear relationship over the described displacementrange.

In an embodiment, a force or load is applied to the forehead support(e.g., from headgear) to flex the forehead support from its originalunloaded position to an operative or adjusted position. The foreheadsupport may be resilient so that it substantially returns to itsoriginal unloaded position when not loaded. Alternatively, the foreheadsupport may be deformable (e.g., plastically deformable, thermallydeformable, malleable) so that it substantially retains its flexed oradjusted position when not loaded.

It should be appreciated that the original, unloaded position of theforehead support may vary. For example, the angle of the foreheadsupport compared to the frame when no load is applied to the mask may bein the range depicted by α in FIG. 6. In an embodiment, α may be about180°-220°, e.g., 200°.

1.2.1 Alternative Original, Unloaded Positions

In its original, unloaded position, the forehead support 20 may bedesigned to press against the patient's forehead, to sit away from thepatient's forehead, or to meet the patient's forehead when no force isapplied. These three alternative positions are depicted in FIGS. 7-1 to9.

FIG. 7-1 illustrates a forehead support 20 that is oriented to sit awayfrom the patient's forehead when no external force is applied. In use,as shown in FIG. 7-2, force from headgear tension or other externalforce in the direction indicated deflects the forehead support 20 untilit is brought into contact with the patient's forehead and anequilibrium is reached between the patient's forehead and the foreheadsupport 20, e.g., forehead padding. That is, the forehead support 20 isadjusted or flexed inwardly to fit to the patient's forehead.

FIG. 8-1 illustrates a forehead support 20 that is oriented to decreasethe angle between the forehead support 20 and the frame 30. When themask is applied to the patient's face, as shown in FIG. 8-2, theforehead support 20 engages the patient's forehead and the reactionforce from the patient's forehead in the direction indicated acts toflex the forehead support 20 away from the patient's face untilequilibrium is achieved. In this arrangement, the spring force of theflexed forehead support 20 equals the reaction force from the patient'sforehead. Thus, the mask provides maximum sealing on the patient's noseand the forehead support 20 is adjusted or flexed outwardly to fit tothe patient's forehead.

FIG. 9 illustrates a forehead support 20 that is oriented to closelyalign or match the forehead support 20 with the patient's forehead sothat no deformation of the forehead support 20 is required or othercomponents of the mask may accommodate for any differences in geometry.That is, the forehead support 20 is structured to engage and achieveequilibrium with the patient's forehead without flexing.

1.3 Spring Constant

The spring constant of the flexible forehead support 20 may becalculated by first determining the maximum amount of pressure that canbe applied to the patient's forehead. The force is then equal to thispressure divided by the effective cross sectional area. The springconstant is equal to this force divided by the displacement of theforehead support. The displacement may be angular, linear, or acombination of both. Hence, the spring constant of the forehead supportis equal to the desired force divided by the displacement of theforehead support.

That is:

T=Fr[Nm]

T=−θk[Nm]

P=F/A[Nm ⁻²]

F=PA[N]

F=T/r[N]

F=−(kθ)/r[N]

k=−(Fr)/θ[Nm/rad]

Where, P=maximum acceptable pressure against patient's forehead;

F=maximum force of forehead support against patient's forehead;

A=effective cross-sectional area of the forehead support that contactsthe patient's forehead;

k=spring constant of flexible forehead support;

T=torque

θ=Angular displacement of forehead support from relaxed to deformedposition; and

r=length of forehead support after the flexing location.

FIG. 10 illustrates the variable θ described above. A range of maximumforces may be used to provide a range of acceptable spring constants asshown in FIG. 11. That is, FIG. 11 illustrates a range of acceptablespring constants with one end of the range having a spring constant thatpasses through a minimum value for the maximum force (F1) at maximumangular displacement and the other end of the range having a springconstant that passes through a maximum value for the maximum force (F2)at maximum angular displacement.

1.4 Limited Axial Rotation

As shown in FIG. 12, the forehead support 20 is structured to provideflexibility but limit the amount of axial rotation or axial twist (asindicated by arrows) that is possible between the portion of theforehead support 20 that contacts the patient's forehead and the frame30. This arrangement prevents instability due to rotation about themedian plane, which can adversely affect the seal. For example, thewidth and/or height of the forehead support 20 may be controlled tominimize axial twist.

1.5 Control of Flexibility

Flexibility provided by the forehead support 20 may be controlled byvarying different aspects of the base 22 of the forehead support 20. Forexample, the material, dimensions, and/or configuration of the base 22may be adjusted to adjust the flexibility.

1.5.1 Cross-Sectional Thickness

In an embodiment, the flexibility of the forehead support 20 and thelocation of the flexibility may be controlled by varying thecross-sectional thickness of the forehead support 20 in the medialplane. For example, controlled flexibility may be achieved by having aforehead support 20 in which the cross-section in the frontal plane(FIG. 13 a) is thicker than the cross-section in the medial plane (FIG.13 b).

1.5.2 Recesses

In the illustrated embodiment, the base 22 of the forehead support 20includes one or more horizontally extending recesses or cut-outs 26along a portion of the length thereof, e.g., s FIGS. 3-1 to 4-8. Asillustrated, the flexible portion 25 of the base 22 includes fourspaced-apart and horizontally aligned recesses 26, each recess 26extending about a perimeter of the base 22. The recesses 26 may have anysuitable width and depth to control flexing of the forehead support.That is, the recesses 26 control the amount and location of flexing ofthe forehead support by controlling the cross-sectional thicknesses inthe frontal and medial planes.

However, the one or more recesses may have other configurations toprovide flexibility, e.g., extend partially around the perimeter,vertically extending.

In addition, the recesses emphasize or provide a visual indication tothe patient that flexing of the forehead support can occur.

In this embodiment, the forehead support is resilient so that itsubstantially returns to its original unloaded position when not loaded,e.g., from headgear.

1.5.3 Ridges

In another embodiment, the axial rotation shown in FIG. 12 may belimited by placing one or more horizontal ridges 28 along all or some ofthe length of the base 22 of the forehead support 20, as shown in FIG.14. This again controls the amount and location of the flexing of theforehead support by controlling the cross-sectional thicknesses in thefrontal and medial planes. The ridges 28 may be comolded with the base22 and may have other suitable configurations to promote bending in aparticular area, e.g., S-shaped.

1.6 Elbow

FIGS. 15-1 to 15-8 illustrate an elbow 50 of the mask 10. The elbow 50includes a first portion 52 structured to interface or otherwise attachto the frame 30 and a second portion 54 provided to a swivel joint 60(e.g., see FIGS. 16-1 to 16-4) adapted to be connected to an airdelivery tube. In addition, the elbow 50 includes a vent arrangement 55for gas washout. As illustrated, the elbow 50 provides a relatively lowprofile, and tapers from a larger internal diameter at the first portion52 to a smaller internal diameter at the second portion 54 (e.g., seeFIG. 15-8).

1.6.1 Frame Attachment

In the illustrated embodiment, the first portion 52 includes opposingflanges or beads 53 along its peripheral edge that are adapted tointerface with or otherwise removably connect to the tube portion 34 ofthe frame 30, e.g., with a snap-fit. As shown in FIG. 15-9, the tubeportion 34 includes a generally part conic shape in which it convergesfrom a larger (outside) diameter to a smaller (inside) diameter. Thisarrangement facilitates insertion of the elbow 50 into the tube portion34 and provides an interference fit to substantially seal the elbow 50to the frame 30. That is, the tube portion 34 is biased radially intothe elbow 50 to provide a connection that allows swivel-type movementbut prevents leak in use. However, other suitable arrangements forattaching the elbow 50 to the frame 30 are possible.

1.6.2 Swivel Joint Attachment

The second portion 54 includes snap-fit tabs 56 to connect the secondportion 54 to the swivel joint 60. As shown in FIG. 16-4, the internalsurface of the swivel joint 60 provides a shoulder 62 to engage thesnap-fit tabs 56.

1.6.3 Vent Arrangement

In the illustrated embodiment, the vent arrangement 55 of the elbow 50is positioned on a slightly contoured surface of the elbow 50 (e.g., seeFIG. 15-7). As illustrated, the vent arrangement 55 includes a pluralityof orifices 57 arranged in concentric circles, e.g., central orificewith concentric circles of orifices arranged about the central orifice.

Each orifice 57 may have a cylindrical configuration (e.g., see FIG.15-8). Alternatively, each orifice may have a generally part conicshape, including opposed walls that converge from a larger (inside)diameter to a smaller (outside) diameter, as viewed in the direction ofexhausted gas.

However, it should be appreciated that the vent arrangement 55 mayinclude other suitable hole configurations, hole arrangements, holenumbers, and/or hole shapes.

2. Second Embodiment of Forehead Support

FIGS. 17-1 to 17-4 illustrate a respiratory mask 210 including aforehead support 220 according to another embodiment of the presentinvention. In this embodiment, the forehead support 220 may bemanufactured from two or more materials to produce a single foreheadsupport element.

As illustrated, the base 222 of the forehead support 220 is constructedof two different materials, i.e., an intermediate portion 225 of thebase 222 is constructed of a different material than the remainder ofthe base (e.g., elastic material or properties). Depending on the degreeof stiffness of each material, which can be determined from the Young'smodulus of the material, and the location of the different materials theamount of flex and the location of the flexion can be controlled.

In the illustrated embodiment, the Young's modulus of the intermediateportion 225 is lower than the rest of the forehead support 220. As aresult, the forehead support 220 is configured to bend at thisintermediate location when force is applied to the forehead support.FIGS. 17-3 and 17-4 illustrate the forehead support 220 in first andsecond deformed positions with respect to the frame 230.

The forehead support 220 may be manufactured in one piece using numeroustechniques, e.g., overmolding, comolding, or dual shot injectionmolding. Alternatively, the different components of the forehead support220 may be manufactured separately and a second process (e.g., the useof adhesives or ultrasonic welding) may be used to combine thesedifferent components into a single element.

In an embodiment, the intermediate portion of the forehead support maybe resilient so that the forehead support substantially returns to itsoriginal unloaded position when not loaded. Alternatively, theintermediate portion of the forehead support may be deformable (e.g.,plastically deformable) so that it substantially retains its flexed oradjusted position when not loaded.

3. Third Embodiment of Forehead Support

Another embodiment includes a flexible forehead support that isstructured to allow easy adjustment by the user. In this embodiment,some or all of the forehead support is manufactured from a material(e.g., polycarbonate (e.g., cold formed), polypropylene, nylon) that canbe plastically deformed into the correct shape using external forces(e.g., manually deform into desired shape). That is, the foreheadsupport may be plastically deformed into a desired position. Theforehead support is then able to deform elastically as it is worn by thepatient, hence providing a close fitting forehead support thatdynamically adapts to the relative movement of the frame and thepatient's forehead thus not disturbing the seal.

This embodiment may be manufactured from one or more materials. Onepossible embodiment includes a malleable wire or metal component that isovermolded with a soft, flexible material (e.g., TPE like material).

In this embodiment, the forehead support is deformable (e.g.,plastically deformable, malleable) so that it substantially retains itsflexed or operative orientation when not loaded.

4. Fourth Embodiment of Forehead Support

Another embodiment relates to a forehead support in which some or all ofthe forehead support is constructed of a material that can be thermallydeformed using hot water or some other heating element (e.g., light,heat) to achieve the desired adjustment. That is, at least the base ofthe forehead support may be constructed of a thermoforming plasticmaterial that can be bent or otherwise self deform to the desiredposition (e.g., flow into contours of the patient's face) when heated upand then sets into such desired position when cooled. This allows acustomized, fixable position for the forehead support.

In an embodiment, once the forehead support had cooled, it would stillretain some ability to flex and/or conform to the patient's head. Also,in an embodiment, the thermal deformation may be repeatable so that theforehead support may be thermally deformed one or more times to changeor update the position of the forehead support.

In an alternative embodiment, at least the base of the forehead supportmay provide a flexible region with a bladder of epoxy. The epoxy isreleased in a suitable manner (e.g., remove plug containing epoxy) whenthe forehead support is deformed to the desired position. The epoxy setsthe forehead support in its desired position when it hardens or sets,e.g., via heat, predetermined time period, etc. Similar to the abovearrangement, this provides a customized, fixable position for theforehead support.

5. Fifth Embodiment of Forehead Support

FIG. 18 illustrates a respiratory mask 310 including a forehead support320 according to another embodiment of the present invention. In thisembodiment, the forehead support 320 is manufactured from two or morematerials and includes a stiff support structure 331 that is connectedto the frame 330 plus a malleable support member 370 (e.g., such as ashape memory alloy, aluminum, magnesium/titanium alloy, or wire, e.g.,nitinol wire) that is then attached to a cross portion 324 of theforehead support. The forehead support 320 can then be easily deformedby bending the malleable support member 370.

As illustrated, the malleable support member 370 may be a metal wireprovided along the base 322 with cut-outs 323 provided in the base 322to expose the malleable support member 370. The cut-outs 323 allow themalleable support member 370 to bend at points along the base 322, andthe malleable support member 370 is structured to hold its desiredposition.

6. Sixth Embodiment of Forehead Support

FIG. 19 illustrates a respiratory mask 410 including a forehead support420 according to another embodiment of the present invention. In thisembodiment, the forehead support 420 includes a second flexible portion427 at the joint between the base 422 and the upper cross portion 424.The second flexible portion 427 may be provided by cut-outs (similar tothe first flexible portion 425) or other suitable configurations, e.g.,living hinge. This arrangement allows the upper cross portion 424 toflex in either direction (counter-rotating) with respect to the base 422to maximize surface area contact with the patient's forehead, e.g.,cross-arm parallel to the patient's forehead. That is, thecounter-rotating second flexible portion 427 allows the forehead support420 to accommodate extreme positions while avoiding edge contact.

It should be appreciated that the forehead support 420 may includeflexible portions (e.g., cut-outs, living hinges, etc.) at othersuitable locations where bending may be desired, e.g., along thecross-portion.

In this embodiment, the first and second flexible portions of theforehead support are resilient so that they substantially return totheir original unloaded positions when not loaded, e.g., from headgear.Alternatively, the first and/or second flexible portions may bedeformable (e.g., plastically deformable, malleable) so that theysubstantially retain their flexed or adjusted positions when not loaded.

7. Seventh Embodiment of Forehead Support

FIGS. 20-1 and 20-2 illustrate a respiratory mask including a foreheadsupport 520 according to another embodiment of the present invention. Inthis embodiment, the forehead support 520 includes a flexible portion525 along the base which allows the forehead support to flex across auseful angular range in any plane and to extend or compress axially inuse. For example, FIG. 20-1 illustrates the forehead support in anunloaded position, and FIG. 20-2 illustrates the forehead support whenloaded and compressed axially. As illustrated, the flexible portion hasa wavy or general s-shape. However, other suitable arrangements arepossible to allow axial compression, e.g., bellows type arrangement.

In an embodiment, the flexible portion may structured such that it isadapted to provide plastic compression or extension and elastic flexingor bending. For example, the flexible portion may be plasticallyextended or compressed to maintain the same height while adaptivelybending across a useful angular range in use. In another embodiment, theflexible portion may provide plastic compression/extension and plasticbending.

Thus, the flexible portion of the forehead support may be structured toprovide an angular and/or axial range of movement, and such movement maybe varied using plastic and/or elastic materials.

While the invention has been described in connection with what arepresently considered to be the most practical and preferred embodiments,it is to be understood that the invention is not to be limited to thedisclosed embodiments, but on the contrary, is intended to cover variousmodifications and equivalent arrangements included within the spirit andscope of the invention. Also, the various embodiments described abovemay be implemented in conjunction with other embodiments, e.g., aspectsof one embodiment may be combined with aspects of another embodiment torealize yet other embodiments. Further, each independent feature orcomponent of any given assembly may constitute an additional embodiment.Furthermore, each individual component of any given assembly, one ormore portions of an individual component of any given assembly, andvarious combinations of components from one or more embodiments mayinclude one or more ornamental design features. In addition, while theinvention has particular application to patients who suffer from OSA, itis to be appreciated that patients who suffer from other illnesses(e.g., congestive heart failure, diabetes, morbid obesity, stroke,bariatric surgery, etc.) can derive benefit from the above teachings.Moreover, the above teachings have applicability with patients andnon-patients alike in non-medical applications.

1. A respiratory mask, comprising: a mask frame; and a forehead supportprovided to the mask frame, the forehead support including a baseextending from the frame, wherein the base includes a flexible portionalong at least a portion of its length including a material and/orphysical characteristic that allows the base to flex from an original,unloaded position.
 2. A respiratory mask according to claim 1, whereinthe flexible portion includes one or more recesses or cut-outs extendingalong at least a portion of the base.
 3. A respiratory mask according toclaim 2, wherein the one or more recesses or cut-outs extendtransversely to the main axis of the frame.
 4. A respiratory maskaccording to claim 2, wherein the one or more recesses or cut-outsextend about a perimeter of the base.
 5. A respiratory mask according toclaim 1, wherein the base includes a cross-section in a frontal planethat is thicker than a cross-section in a medial plane.
 6. A respiratorymask according to claim 1, wherein at least the flexible portion isconstructed of a resilient material that allows the forehead support tosubstantially return to its original position when not loaded.
 7. Arespiratory mask according to claim 1, wherein the base is flexible inopposing directions from the original, unloaded position.
 8. Arespiratory mask according to claim 7, wherein the base is flexible upto about 50 mm in opposing directions from the original, unloadedposition.
 9. A respiratory mask according to claim 1, wherein theforehead support is structured to press against the patient's foreheadin the original, unloaded position.
 10. A respiratory mask according toclaim 1, wherein the forehead support is structured to sit away from thepatient's forehead in the original, unloaded position.
 11. A respiratorymask according to claim 1, wherein the forehead support is structured tomeet the patient's forehead in the original, unloaded position.
 12. Arespiratory mask according to claim 1, wherein the forehead support isstructured to provide flexibility towards and away from the patient'sface and to allow limited axial flex or rotation along the longitudinalaxis of the base.
 13. A respiratory mask according to claim 1, whereinthe flexible portion allows auto-fitting of the mask.
 14. A respiratorymask according to claim 1, wherein the frame and forehead support areintegrally formed in one piece.
 15. A respiratory mask according toclaim 1, wherein headgear connectors are provided to respective sides ofthe frame, each headgear connector being in the form of an outriggerincluding an elongated arm and a tab portion that provides a slotadapted to receive a respective headgear strap in use.
 16. A respiratorymask according to claim 1, wherein the forehead support has a general“T”-shape with an upper cross-portion provided to the base.
 17. Arespiratory mask according to claim 16, wherein the upper cross portionincludes slots adapted to receive respective headgear straps in use. 18.A respiratory mask according to claim 16, wherein the uppercross-portion is structured to retain one or more forehead pads.
 19. Arespiratory mask according to claim 1, wherein the base is contouredalong its length.
 20. A respiratory mask according to claim 1, furthercomprising an elbow provided to the mask frame, the mask frame includinga tube portion with a part conic shape that is biased radially into theelbow to provide a connection.
 21. A respiratory mask according to claim1, further comprising an upper cross portion provided to the base and asecond flexible portion at the joint between the base and the uppercross portion which allows the upper cross portion to flex relative tothe base.
 22. A respiratory mask according to claim 21, wherein thesecond flexible portion includes one or more recesses or cut-outsextending along at least a portion of the base.
 23. A respiratory mask,comprising: a mask frame; and a forehead support provided to the maskframe, the forehead support including a base extending from the frame,wherein the base includes a flexible portion along at least a portion ofits length which allows the base to flex from an original, unloadedposition, the flexible portion constructed of a different material thanthe remainder of the base.
 24. A respiratory mask according to claim 23,wherein at least the flexible portion is constructed of a resilientmaterial that allows the forehead support to substantially return to itsoriginal position when not loaded.
 25. A respiratory mask, comprising: amask frame; and a forehead support provided to the mask frame, theforehead support including a base extending from the frame, wherein thebase includes a bendable portion along at least a portion of its lengthwhich allows the base to bend from an original position to an adjustedposition such that the bendable portion retains the adjusted positionfor forces less than a certain limit, the bendable portion including adeformable or malleable material.
 26. A respiratory mask according toclaim 25, wherein the bendable portion is plastically deformable.
 27. Arespiratory mask according to claim 25, wherein the bendable portion isthermally deformable.
 28. A respiratory mask according to claim 25,wherein the bendable portion includes a malleable metal.
 29. Arespiratory mask according to claim 25, wherein the bendable portion isreadjustable from the adjusted position.
 30. A respiratory maskaccording to claim 25, wherein the bendable portion is set in theadjusted position.
 31. A respiratory mask according to claim 25, whereinthe bendable portion is resiliently flexible from the adjusted positionfor forces less than the certain limit.
 32. A respiratory mask accordingto claim 25, wherein the bendable portion is constructed ofpolycarbonate, polypropylene, or nylon.
 33. A respiratory mask accordingto claim 25, wherein the bendable portion includes an epoxy structuredto set the base in the adjusted position.
 34. A respiratory mask,comprising: a mask frame adapted to support an elbow; and a foreheadsupport integrally formed in one piece with the mask frame, the foreheadsupport including a general “T”-shape with a base extending from theframe and an upper cross-portion provided to the base, wherein the baseincludes a flexible portion along at least a portion of its length thatis constructed of a resilient material that allows the base to flex froman original, unloaded position and substantially return to its originalposition when not loaded.
 35. A respiratory mask according to claim 34,wherein the base includes a cross-section in a frontal plane that isthicker than a cross-section in a medial plane.
 36. A respiratory maskaccording to claim 34, wherein the upper cross portion includes slotsadapted to receive respective headgear straps in use.
 37. A respiratorymask according to claim 34, further comprising one or more forehead padsprovided to the upper cross-portion.
 38. A respiratory mask, comprising:a mask frame; and a forehead support provided to the mask frame, theforehead support including a base extending from the frame, wherein thebase includes a flexible portion along at least a portion of its lengththat allows the forehead support to flex across a useful angular rangein any plane and/or to extend or compress axially.
 39. A respiratorymask according to claim 38, wherein the flexible portion is structuredsuch that it is adapted to plastically extend or compress axially andelastically flex across a useful angular range.
 40. A respiratory maskaccording to claim 38, wherein the flexible portion is structured suchthat it is adapted to plastically extend or compress axially andplastically flex across a useful angular range.